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Study to Evaluate the Pharmacokinetic Comparability of CC-93538 From Two Different Drug Concentrations in Healthy Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04373187
Recruitment Status : Not yet recruiting
First Posted : May 4, 2020
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

This is an open-label, randomized, parallel design study to evaluate the PK comparability, safety, tolerability and immunogenicity of a single SC dose of 360 mg CC 93538 using two different drug concentrations, 180 mg/mL and 150 mg/mL, in healthy adult subjects.

A total of approximately 52 subjects will be enrolled and randomized 1:1 to receive a single 360 mg SC dose of CC-93538 using either 180 mg/mL (1 injection of 2 mL) or 150 mg/mL (2 injections of 1.2 mL each) drug concentrations.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: CC-93538 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Two Different Dose Concentrations of CC-93538 in Healthy Adult Subjects
Estimated Study Start Date : May 21, 2020
Estimated Primary Completion Date : October 13, 2020
Estimated Study Completion Date : October 13, 2020

Arm Intervention/treatment
Experimental: CC-93538, 180mg/mL
26 healthy subjects will receive one injection of 2mL, 180mg/mL CC-93538
Drug: CC-93538
one injection of 2mL

Experimental: CC-93538, 150mg/mL
26 healthy subjects will receive 2 injections of 1.2mL, 150mg/mL CC-93538
Drug: CC-93538
one injection of 2mL

Drug: CC-93538
two injections of 1.2mL




Primary Outcome Measures :
  1. Pharmacokinetic - AUC0-∞ [ Time Frame: From Day 0 to Day 105 ]
    Area under the concentration-time curve calculated from time zero to infinity

  2. Pharmacokinetic - Cmax [ Time Frame: From Day 0 to Day 105 ]
    Maximum observed concentration of drug


Secondary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: From enrollment to Day 105 ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

  2. Pharmacokinetic - AUC0-last [ Time Frame: From Day 0 to Day 105 ]
    Area under the concentration-time curve calculated from time zero to the last measured time point

  3. Pharmacokinetic - tmax [ Time Frame: From Day 0 to Day 105 ]
    Time to Cmax

  4. Pharmacokinetic - t½ [ Time Frame: From Day 0 to Day 105 ]
    Terminal elimination half-life

  5. Pharmacokinetic - CL/F [ Time Frame: From Day 0 to Day 105 ]
    Apparent clearance of drug from serum after extravascular administration

  6. Pharmacokinetic - Vz/F [ Time Frame: From Day 0 to Day 105 ]
    Apparent volume of distribution during the terminal phase



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  1. Subject must be male or non-pregnant female, aged ≥ 18 and ≤ 55 years of age at the time of signing the ICF.
  2. Subject must have a body weight of at least 40 kg; a BMI ≥ 18 and ≤ 30 kg/m2 at screening and Day -1.
  3. Subject must be in good health, as determined by the Investigator on the basis of medical history, clinical laboratory safety test results, vital signs, 12-lead ECG, and PE at Screening.
  4. Female subjects not of childbearing potential must:

    1. Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before Screening, or
    2. Postmenopausal (defined as 24 consecutive months without menses before Screening, with a follicle stimulating hormone [FSH] level in the postmenopausal range according to the laboratory used at Screening); FSH to be performed at the discretion of the Investigator in consultation with the Medical Monitor.

    Females of child-bearing potential (FCBP) must agree to practice a highly effective method of contraception throughout the study and for 5 months after the last dose of investigational product (IP). FCBP is a female who 1) has achieved menarche at some point; 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).

    Acceptable methods of birth control in this study are the following:

    • Combined hormonal (containing oestrogen and progestogen) contraception, which may be oral, intravaginal, or transdermal
    • Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable or implantable
    • Placement of an intrauterine device or intrauterine hormone-releasing system
    • Bilateral tubal occlusion
    • Vasectomised partner
    • Sexual abstinence
  5. Subjects must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted, and must be able to comply with the requirements of the study, including the study visit schedule and other protocol requirements. Must be able to communicate with the Investigator and to understand and adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

  1. Subject has any significant medical history/condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  2. Subject has any condition (acute or chronic) including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  3. Subject has any condition that confounds the ability to interpret data from the study.
  4. Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, ifkn own (whichever was longer).
  5. Subject has previously received CC-93538 treatment (formerly known as RPC4046 and ABT-308).
  6. Subject has a history of infection within 30 days of dosing on Day 1.
  7. Subject has a history of drug or alcohol abuse (as defined by the investigator), or addiction within 6 months prior to Screening.
  8. Subject has a positive urine drug test, or positive alcohol urine or breath test at Screening or on Day -1.
  9. Subject has donated greater than 400 mL of blood within 60 days prior to Day 1.
  10. Subject has a positive serum test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
  11. Subject has a history of clinically significant allergic reaction to any drug, biologic, food, or vaccine.
  12. Subject has a history of major immunologic reaction (such as anaphylactic reaction, anaphylactoid reaction, or serum sickness) to any IgG-containing agent.
  13. Subject fails or is unwilling to abstain from strenuous physical activities for at least 24 hours prior to dosing (Day 1) and throughout the study
  14. Subject has tattoos (> 25% of their body) or other skin markings (eg, scars) that, in the opinion of the investigator, would prevent visualization of dermatologic changes due to study treatment
  15. Subject has an active parasitic/helminthic infection or suspected parasitic helminthic infection. Subjects with suspected infections may participate if clinical and laboratory
  16. Subject has been diagnosed with or is being treated for a clinical schistosomiasis.
  17. Subject has a history of tuberculosis, or listeriosis.
  18. Subject has a history of hereditary fructose intolerance.
  19. Subject is, for any reason, deemed by the Investigator to be inappropriate for this study.
  20. Subject has received any drug by injection within 30 days of Day 1.
  21. Subject has poor peripheral venous access.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373187


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Sponsors and Collaborators
Celgene
Investigators
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Study Director: Peijin Zhang, M.D., PhD Bristol-Myers Squibb
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04373187    
Other Study ID Numbers: CC-93538-CP-002
U1111-1250-3915 ( Other Identifier: WHO )
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
CC-93538
Healthy Subjects
PK comparability between two different dose concentrations